Alignment instruments and methods for use in total ankle replacement

ABSTRACT

Alignment instruments may include joint-line referencing systems having an alignment arm having a body with first and second portions defining first and second sides. The first portion has at least one first pin tube through-hole extending from the first to the second side. The second portion has a first opening on the first side. A pin tube guide member is receivable in the first through-hole. The pin tube guide member has a passageway therethrough. An angelwing alignment member includes a portion receivable in the first opening of the alignment arm. An alignment foot is secured to the second portion, and the alignment foot has a handle and a shim. The shim is positionable in a joint between a first bone and a second bone, the alignment arm is alignable relative to a first bone, and the pin tube guide is operable for securing a pin into the first bone.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Patent ApplicationNo. PCT/US2019/066149, filed on Dec. 13, 2019, entitled “AlignmentInstruments And Methods For Use In Total Ankle Replacement” (AttorneyDocket No. 3645.156AWO), which international patent application claimspriority benefit under 35 U.S.C. § 119(e) of U.S. Provisional PatentApplication No. 62/899,655, filed Sep. 12, 2019, entitled “AlignmentInstruments And Methods For Use In Total Ankle Replacement” (AttorneyDocket No. 3645.156P1), and which international patent applicationclaims priority benefit under 35 U.S.C. § 119(e) of U.S. ProvisionalPatent Application No. 62/779,436, filed Dec. 13, 2018, entitled “JointReplacement Systems And Methods Of Use And Assembly” (Attorney DocketNo. 3645.138P), which applications are hereby incorporated herein byreference in their entireties.

TECHNICAL FIELD

The present disclosure relates generally to general, podiatric, andorthopaedic surgery related to joint deformities. More specifically, butnot exclusively, the present disclosure relates to instruments, systems,and methods for maintaining, correcting and/or resurfacing jointsurfaces.

BACKGROUND

Typically, implant alignment or guide systems attach to a patient, suchas to one or more bones of an extremity of the patient. For example, inan ankle joint replacement system or surgery, an alignment guide istypically attached to the patient's foot and along the length of thetibia bone (e.g., via pins, k-wire or other removable mechanicalfasteners).

SUMMARY

Aspects of the present disclosure provide implant alignment instruments,guides, methods, and systems for correcting bone deformities in the footand ankle. Shortcomings of the prior art are overcome and additionaladvantages are provided through the provision in one embodiment of ajoint-line referencing system, which includes, for example, an alignmentarm having a body with a first portion and a second portion. The firstportion and the second portions define a first side and a second side.The first portion has at least one first pin tube through-hole extendingfrom the first side to the second side. The second portion has a firstopening on the first side. A first pin tube guide member is receivablein the at least one first pin tube through-hole. The first pin tubeguide member has a passageway therethrough. An angelwing alignmentmember includes a portion receivable in the at least one first openingof the alignment arm. An alignment foot is secured to the secondportion, and the alignment foot has a handle extending away from thefirst side and a shim extending away from the second side. The shim ispositionable in a joint between a first bone and a second bone, thealignment arm is alignable relative to a first bone, and the pin tubeguide is operable for securing a pin into the first bone.

In another embodiment, a surgical method includes, for example,providing the above joint-line referencing system placing the shim ofthe alignment foot into a joint between a tibia and a talus of apatient, inserting the pin tube guide member in the at least one pintube hole of the alignment arm, moving the handle of the alignment footto orient the alignment arm, inserting a first pin in the passageway ofthe pin tube guide member and into the tibia of the patient, andremoving the joint-line referencing system from the joint and the firstpin.

In another embodiment, a surgical method includes, for example,providing the above joint-line referencing system, placing the shim ofthe alignment foot into a joint between a tibia and a talus of apatient, inserting the pin tube guide member in the at least one firstpin tube through-hole of the alignment arm, inserting a second pin tubeguide member in a second pin tube hole of the alignment arm, moving thehandle of the alignment foot to orient the alignment arm, inserting afirst pin in the first passageway of the first pin tube guide member andinto the tibia of the patient, inserting a second pin in the secondpassageway of the second pin tube guide member and into the tibia of thepatient, and removing the joint-line referencing system from the jointand the first and second pins.

In another embodiment, a surgical method includes, for example, placinga shim into a joint between a first bone and a second bone of a patient,moving a handle operably attached to the shim to position and/or orientan alignment arm relative to the first bone, inserting a first pinthrough a hole of the alignment arm and into the first bone, andremoving the shim from the joint and the alignment arm from the firstpin.

In another embodiment, a joint line pointer includes, for example, abody and an elongated handle. The body includes a first side, a secondside, and an upper portion having a coupling member for coupling to analignment system. The elongated handle includes a first end attached toa first side of said body. A lower portion of the body includes a firstlaterally-extending portion having a distal end extending between saidfirst side and said second side, and a second laterally-extendingportion having a distal end extending between said first side and saidsecond side. The first and second laterally-extending portions arealignable with a joint line between a first bone and a second bone.

These and other objects, features and advantages of the presentdisclosure will become apparent from the following detailed descriptionof the various embodiments of the present disclosure taken inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the presentdisclosure and together with the detailed description herein, serve toexplain the principles of the present disclosure. The drawings are onlyfor purposes of illustrating preferred embodiments and are not to beconstrued as limiting the present disclosure. It is emphasized that, inaccordance with the standard practice in the industry, various featuresare not drawn to scale. In fact, the dimensions of the various featuresmay be arbitrarily increased or reduced for clarity of discussion. Theforegoing and other objects, features and advantages of the disclosureare apparent from the following detailed description taken inconjunction with the accompanying drawings in which:

FIG. 1 is a perspective view of a joint-line referencing system,according to an embodiment of the present disclosure;

FIG. 2 is a front elevational view of the joint-line referencing systemof FIG. 1, according to an embodiment of the present disclosure;

FIG. 3 is a rear elevational view of the joint-line referencing systemof FIG. 1, according to an embodiment of the present disclosure;

FIG. 4 is a first side elevational view of the joint-line referencingsystem of FIG. 1, according to an embodiment of the present disclosure;

FIG. 5 is a second side elevational view of the joint-line referencingsystem of FIG. 1, according to an embodiment of the present disclosure;

FIG. 6 is a top view of the joint-line referencing system of FIG. 1,according to an embodiment of the present disclosure;

FIG. 7 is a bottom view of the joint-line referencing system of FIG. 1,according to an embodiment of the present disclosure;

FIG. 8 is an exploded, top perspective view of the joint-linereferencing system of FIG. 1, according to an embodiment of the presentdisclosure;

FIG. 9 is an exploded, top perspective view of the joint-linereferencing system of FIG. 1, according to an embodiment of the presentdisclosure;

FIG. 10 is an exploded, bottom perspective view of the joint-linereferencing system of FIG. 1, according to an embodiment of the presentdisclosure;

FIG. 11 is an exploded, bottom perspective view of the joint-linereferencing system of FIG. 1, according to an embodiment of the presentdisclosure;

FIG. 12 is a front elevational view of the joint-line referencing systemof FIG. 1 positioned relative to a patient's lower extremity, accordingto an embodiment of the present disclosure;

FIG. 13 is a side elevational view of the joint-line referencing systemof FIG. 12 and a pin attached to the patient's lower extremity,according to an embodiment of the present disclosure;

FIG. 14 is a perspective view of the joint-line referencing system ofFIG. 12 and a pin attached to a patient's lower extremity, according toan embodiment of the present disclosure;

FIG. 15 is a perspective view of the patient's lower extremity with thepin attached to the patient's lower extremity after removal of thejoint-line referencing system of FIG. 12, according to an embodiment ofthe present disclosure;

FIG. 16 is a perspective view of the patient's lower extremity and thepin of FIG. 15, and a tibia alignment guide (TAG) tower, according to anembodiment of the present disclosure;

FIG. 17 is a side elevational view of the lower extremity, the pin, andthe TAG tower of FIG. 16, according to an embodiment of the presentdisclosure;

FIG. 18 is an enlarged, front elevational view of the proximal portionof the patient's lower extremity and the TAG tower of FIG. 16, accordingto an embodiment of the present disclosure;

FIG. 19 is an enlarged, front elevational view of the distal portion ofthe patient's lower extremity and the TAG tower of FIG. 16, according toan embodiment of the present disclosure;

FIG. 20 is a top perspective view of a joint-line referencing system,according to an embodiment of the present disclosure;

FIG. 21 is a top perspective view of the joint-line referencing systemof FIG. 20, according to an embodiment of the present disclosure;

FIG. 22 is a bottom perspective view of the joint-line referencingsystem of FIG. 20, according to an embodiment of the present disclosure;

FIG. 23 is a side elevational view of the joint-line referencing systemof FIG. 20, according to an embodiment of the present disclosure;

FIG. 24 is a front elevational view of the joint-line referencing systemof FIG. 20, according to an embodiment of the present disclosure;

FIG. 25 is a perspective view of the joint-line referencing system ofFIG. 20 and pins attached to a patient's lower extremity, according toan embodiment of the present disclosure;

FIG. 26 is a perspective view of the patient's lower extremity with thepins attached to the patient's lower extremity after removal of thejoint-line referencing system of FIG. 20, according to an embodiment ofthe present disclosure;

FIG. 27 is a front view of a fast-track alignment system, according toan embodiment of the present disclosure;

FIG. 28 is a bottom perspective view of the fast-track alignment systemof FIG. 27, according to an embodiment of the present disclosure;

FIG. 29 is a perspective view of the fast-track alignment system of FIG.27 positioned on a patient's lower extremity with a sizing block coupledto the distal end of the fast-track alignment system and an angelwingalignment member coupled to the sizing block, according to an embodimentof the present disclosure;

FIG. 30 is an enlarged, front view of the fast-track alignment system ofFIG. 29 and the patient's lower extremity, according to an embodiment ofthe present disclosure;

FIG. 31 is a perspective view of a fast-track alignment system and ajoint line pointer positioned on a patient's lower extremity, accordingto an embodiment of the present disclosure;

FIG. 32 is a front elevational view of the fast-track alignment systemand the joint line pointer of FIG. 31, according to an embodiment of thepresent disclosure;

FIG. 33 is a perspective view of the fast-track alignment system and thejoint line pointer of FIG. 31, according to an embodiment of the presentdisclosure;

FIG. 34 is a perspective view of the fast-track alignment system and thejoint line pointer of FIG. 31, according to an embodiment of the presentdisclosure;

FIG. 35 is an exploded, top perspective view of the fast-track alignmentsystem and the joint line pointer of FIG. 31, according to an embodimentof the present disclosure;

FIG. 36 is an exploded, bottom perspective view of the fast-trackalignment system and the joint line pointer of FIG. 31, according to anembodiment of the present disclosure;

FIG. 37 is a perspective view of the joint line pointer of FIG. 31,according to an embodiment of the present disclosure;

FIG. 38 is a front elevational view of the joint line pointer of FIG.37, according to an embodiment of the present disclosure;

FIG. 39 is a side elevational view of the joint line pointer of FIG. 37,according to an embodiment of the present disclosure;

FIG. 40 is a top view of the joint line pointer of FIG. 37, according toan embodiment of the present disclosure;

FIG. 41 is a perspective view of a joint line pointer, according to anembodiment of the present disclosure;

FIG. 42 is a perspective view of the joint line pointer of FIG. 41,according to an embodiment of the present disclosure;

FIG. 43 is a side elevational view of the joint line pointer of FIG. 41,according to an embodiment of the present disclosure;

FIG. 44 is a top view of the joint line pointer of FIG. 41, according toan embodiment of the present disclosure;

FIG. 45 is a perspective view of a joint-line referencing system,according to an embodiment of the present disclosure;

FIG. 46 is a front elevational view of the alignment arm, angelwingalignment member, and alignment foot of the joint-line referencingsystem of FIG. 45, according to an embodiment of the present disclosure;

FIG. 47 is a rear elevational view of the alignment arm, angelwingalignment member, and alignment foot of the joint-line referencingsystem of FIG. 45, according to an embodiment of the present disclosure;

FIG. 48 is a first side elevational view of the alignment arm, angelwingalignment member, and alignment foot of the joint-line referencingsystem of FIG. 45, according to an embodiment of the present disclosure;

FIG. 49 is a second side elevational view of the alignment arm,angelwing alignment member, and alignment foot of the joint-linereferencing system of FIG. 45, according to an embodiment of the presentdisclosure;

FIG. 50 is a top view of the alignment arm, angelwing alignment member,and alignment foot of the joint-line referencing system of FIG. 45,according to an embodiment of the present disclosure;

FIG. 51 is a bottom view of the alignment arm, angelwing alignmentmember, and alignment foot of the joint-line system of FIG. 45,according to an embodiment of the present disclosure;

FIG. 52 is an exploded, top perspective view of the alignment arm,angelwing alignment member, and alignment foot of the joint-linereferencing system of FIG. 45, according to an embodiment of the presentdisclosure;

FIG. 53 is an exploded, bottom perspective view of the alignment arm andalignment foot of the joint-line referencing system of FIG. 45,according to an embodiment of the present disclosure;

FIG. 54 is an enlarged, front perspective view of the alignment arm ofthe joint-line referencing system of FIG. 45, according to an embodimentof the present disclosure;

FIG. 55 is an enlarged, rear perspective view of the alignment arm ofthe joint-line referencing system of FIG. 45, according to an embodimentof the present disclosure;

FIG. 56 is an enlarged, top perspective view of the shim of thealignment foot of the joint-line referencing system of FIG. 45,according to an embodiment of the present disclosure;

FIG. 57 is a bottom perspective view of the shim of FIG. 56, accordingto an embodiment of the present disclosure;

FIG. 58 is a top view of the shim of FIG. 56, according to an embodimentof the present disclosure;

FIG. 59 is a side view of the shim of FIG. 58, according to anembodiment of the present disclosure;

FIG. 60 is a front view of the joint-line referencing system of FIG. 45positioned relative to a patient's lower extremity, according to anembodiment of the present disclosure;

FIG. 61 is a side view of the joint-line referencing system of FIG. 60and pins attached to the patient's lower extremity, according to anembodiment of the present disclosure;

FIG. 62 is a perspective view of the joint-line referencing system ofFIG. 45 with a laser alignment system, according to an embodiment of thepresent disclosure;

FIG. 63 is a perspective view of the laser alignment system of FIG. 62,according to an embodiment of the present disclosure;

FIG. 64 is a perspective view, partially cut away, of the laseralignment system of FIG. 62, according to an embodiment of the presentdisclosure;

FIG. 65 is an exploded perspective view of the laser alignment system ofFIG. 62, according to an embodiment of the present disclosure;

FIG. 66 is a side perspective view of the joint-line referencing systemand laser alignment system of FIG. 62 aligned with a patient's lowerextremity, according to an embodiment of the present disclosure;

FIG. 67 is a front perspective view of the joint-line referencing systemand the laser alignment system of FIG. 66 aligned with a patient's lowerextremity, according to an embodiment of the present disclosure;

FIG. 68 is a flowchart of a surgical method, according to an embodimentof the present disclosure; and

FIG. 69 is a flowchart of a surgical method, according to an embodimentof the present disclosure.

DETAILED DESCRIPTION

Generally stated, disclosed herein are apparatus and methods for anklereplacement surgery and correction of bone deformities in the foot andankle.

The present disclosure is directed to instruments, guides, systems andrelated methods for, for example, total ankle replacement prostheses.The instruments, guides, systems and related methods may facilitatepreparation of a tibia and/or talus of a patient for implantation of atotal ankle prosthesis therein. The instruments, guides, systems andrelated methods may also facilitate selection of a particular size of atibial trialing component, tibial implant component, a talus trialingcomponent, a talus implant component, and/or a tibial insert of thetotal ankle prosthesis that suits the patient. The instruments, guides,systems and methods facilitate proper alignment of the implant with themechanical axis of an extremity of a patient. In some embodiments, theinstruments, guides, systems and methods may facilitate bone resectionand implantation of an implant into one or more bones so that theimplant is properly aligned with the mechanical axis (or another axis oranatomical axis or reference point) of the extremity of a patient. Theinstruments, guides, systems and methods of the present disclosure maybe utilized with any anatomical structure(s) of a patient to facilitatebone resection and alignment of an implant with an axis (e.g.,mechanical axis, weight-bearing axis, anatomical axis, etc.) of one ormore anatomical structures of interest.

In this detailed description and the following claims, the wordsproximal, distal, anterior or plantar, posterior or dorsal, medial,lateral, superior and inferior are defined by their standard usage forindicating a particular part or portion of a bone, joint (or any otheranatomical structure) or implant according to the relative dispositionof the natural bone, joint (or any other anatomical structure) ordirectional terms of reference. For example, “proximal” means theportion of a device or instrument nearest the torso, while “distal”indicates the portion of the device or instrument farthest from thetorso. As for directional terms, “anterior” is a direction towards thefront side of the body, “posterior” means a direction towards the backside of the body, “medial” means towards the midline of the body,“lateral” is a direction towards the sides or away from the midline ofthe body, “superior” means a direction above and “inferior” means adirection below another object or structure. Further, specifically inregard to the foot and/or ankle, the term “dorsal” refers to the top ofthe foot and the term “plantar” refers the bottom of the foot.

Similarly, positions or directions may be used herein with reference toanatomical structures or surfaces. For example, as the currentinstruments, guides, systems and related methods (and componentsthereof) are described herein with reference to use with the bones ofthe ankle, the bones of the foot, ankle and lower leg may be used todescribe the surfaces, positions, directions or orientations of theinstruments, guides, systems and related methods (and componentsthereof). Further, the instruments, guides, systems and related methods,and the aspects, components, features and the like thereof, disclosedherein may be described with respect to one side of the body (e.g., theleft or right ankle) for brevity purposes. However, as the human body isrelatively symmetrical or mirrored about a line of symmetry (midline),it is hereby expressly contemplated that the instruments, guides,systems and related methods, and the aspects, components, features andthe like thereof, described and/or illustrated herein may be changed,varied, modified, reconfigured or otherwise altered for use orassociation with another side of the body for a same or similar purposewithout departing from the spirit and scope of the disclosure. Forexample, the instruments, guides, systems and related methods, and theaspects, components, features and the like thereof, described hereinwith respect to the right ankle of a patient may be mirrored so thatthey likewise function with the left ankle of the patient. Further, theinstruments, guides, systems and related methods, and the aspects,components, features and the like thereof, disclosed herein aredescribed with respect to the ankle for brevity purposes, but it shouldbe understood that the instruments, guides, systems and related methods(and components thereof) may be used with other joints of a human body(or other mammalian body).

The present disclosure may provide implant guides, devices, systems, andmethods for total ankle replacements and correction of bone deformitiesin the foot and ankle. For example, in some embodiments, the joint-linereferencing systems described herein may optimize positioning designedto fit the talar and tibial curvature in both anterior-posterior andmedial-lateral directions. In particular, the joint-line referencingsystems may allow for the streamlining of surgical techniques,improvement in the accuracy of surgery set-up procedures, and reductionof the likelihood of misplacement of bone screws.

With reference to FIG. 1-11, therein illustrated is a joint-linereferencing system 100, according to an embodiment of the presentdisclosure. For example, in some embodiments, the joint-line referencingsystem 100 is operable with a tibia alignment guide (TAG) tower 300(FIG. 16), as described in greater detail below. In this illustratedembodiment, the joint-line referencing system 100 may include, forexample, an alignment arm 200, a pin tube guide member 250, an angelwingalignment member 260, and an alignment foot 110 having a handle 150 anda curved shim 112.

In this exemplary embodiment, the alignment arm 200 may include a body210 having a first portion 212 and a second portion 214. The firstportion 212 of the alignment arm 200 may include a pin tube holder 220defining at least one pin tube through-hole 222 for receiving the pintube guide member 250. A pin tube through-hole 216 is operable forreceiving a second pin tube guide member (FIG. 20) for use with afast-track alignment system 600 (FIG. 27) as described in greater detailbelow. The at least one pin tube through-hole 222 may be separateindividual side-by-side holes or a plurality of overlapping pin tubethrough-holes that allow for anatomic variations. The at least one pintube through-hole 222 may be, for example, three holes as shown in thedepicted embodiment to allow for anatomic variations. The at least onepin tube through-hole 222 (and the pin tube through-hole 216) may beoblong or elongated to allow easier removal of the shim 112 from thejoint while leaving one or more pins or guidewires in place, forexample, by reducing binding, as described below.

With reference to FIG. 8, the second portion 214 of the alignment arm200 may include a base portion 230 having a slot 232 for receiving anauxiliary alignment instrument such as a tab 274 of the angelwingalignment member 260, or a laser alignment device (not shown), or othersuitable alignment device. A distal end of the base portion 230 mayfurther include a hinge portion with a first hinge arm or first femalehinge member 234 and a spaced-apart second hinge arm or second femalehinge member 234, which members have aligned hinge pin openings 236.

The pin tube guide member 250 may contain a knob 252 coupled to a firstend of a shaft 254. The shaft 254 is sized for extending through one ofthe plurality of pin tube through-holes 222 and 216. The pin tube guidemember 250 includes a passageway 256 extending through the knob 252 andthe shaft 254. The second end of the shaft 254 may be, for example,tapered. The pin tube guide member 250 may be, for example, sized andshaped or configured to receive a 3.0 millimeter (mm) or other sizebone-pin.

The angelwing alignment member 260 may have a body 262. For example, thebody 262 may be a planar member having an L-shaped configurationdefining a first end portion 276 and a second end portion 268. The tab274 extends from first end portion 276. The tab 274 may be, for example,sized and shaped to be received in or engage the slot 232 of thealignment arm 200. The body 262 may include cutouts 270 to assist ininsertion of tab 274 into the slot 232 of the base portion 230 of thealignment arm 200. The second end portion 268 may include an elongatedslot 264 with an enlarged opening for receiving and coupling to anelongate auxiliary alignment member or a rod 280 (FIG. 16).

The angelwing alignment member 260 allows a surgeon to assess the tibialslope. For example, the rod 280 may be movably coupled to the angelwingalignment member 260, such as within the slot 264 of the angelwingalignment member 260, which slot may extend anteriorly-posteriorly. Therod 280 may be oriented perpendicular (in at least one direction) ornormal to the angelwing alignment member 260, and thereby perpendicular(in at least one direction) or normal to the joint line referenced bythe slot 232 in base portion 230 and the angelwing alignment member 260.The rod 280 may thereby allow a user to determine/evaluate the alignment(e.g., sagittal alignment) and/or orientation (e.g., sagittal slopeand/or coronal slope) of the joint line of the anatomicalconfiguration/structures of the patient (e.g., an ankle joint) and/or ofa particular implant replacing such configuration/structures (e.g., atotal ankle replacement implant) implanted on/in a resected bone that isresected (at least partially).

With reference still to FIG. 8, the alignment foot 110 may include thehandle 150 attached to the curved shim 112. The curved shim may includecurved alignment feet 120 having spaced apart ends 118 (FIG. 1). Thecurved alignment feet 120 are designed to fit the talar and tibialcurvature in anterior-posterior and medial-lateral directions. A portion136 disposed between the handle 150 and the curved shim 112 may includehinge pin opening 138.

With reference again to FIGS. 4 and 5, the handle 150 is pivotallyattached to alignment arm 200 with the portion 136 (FIG. 8) beingpositioned between hinge members 234 via a fastener pin 240 (FIG. 8) orother suitable pivoting member. The pivotable connection allows asurgeon to adjust the tibia slope. The first portion 212 of alignmentarm 200 is disposed at an angle A relative to the second portion 214.The angled relationship provides an offset/clearance to allow for“negative” tibia slope. In other embodiments, the alignment arm 200 maybe, for example, straight or may include a bend, curve or angulationbetween the first portion and the second portion. The handle 150 allowsa surgeon to orient the joint-line referencing system 100 in transverseplane or internal-external rotation.

FIGS. 12-19 illustrate an alignment procedure, which includes ajoint-line referencing (JLR) and the tibia alignment guide (TAG)technique for use in a TAR surgery, according to an embodiment of thepresent disclosure.

As shown in FIGS. 12 and 13, a surgical method includes placing the shim112 (FIG. 1) of the alignment foot 110 into the joint 10 between thetibia 12 and the talus 14 of the patient. Specifically, the shim 112 isplaced between the tibia plafond and the superior talar dome. The handle150 may be used, for example, to position and/or orient the alignmentfoot 110, and thus, the coupled alignment arm 200, in a transverse plane(i.e., internal-external rotation).

Next, the angelwing alignment member 260 is inserted into the slot 232(FIG. 8) of the base portion 230 (FIG. 8) of the alignment arm 200 maybe used by a surgeon to assess the tibial slope. As shown in FIG. 12,the joint-line referencing system 100 may be utilized and positionedand/or orientated with respect to any axis X-X of the anatomicalstructure of interest. After the desired position and/or orientation ofthe joint-line referencing system 100 is achieved, a pin 290 inserted inpin hole 256 (FIG. 8) of guide member 250 and drilled into the tibia 12,as shown in FIG. 14. The inserted pin 290 secures the selected tibialslope and internal-external rotation.

With reference to FIG. 15, the joint line referencing system 100 (FIG.14) may be removed, whereby the pin 290 remains inserted into the tibia12. For example, the pin tube guide member 250 (FIG. 14) may be removed,and simultaneously the alignment arm 200 (FIG. 14) may be simultaneouslyremoved from the pin 290 and the shim 112 (FIG. 1) removed from thejoint. The irregular shaped pin tube through-holes 222 allow formovement and removal of the joint-line reference system 100. The pin 290serves as the starting point for the next portion of the surgicalprocedure, i.e., the TAG technique.

As shown in FIG. 16, a second pin 390 may then be drilled into theproximal tibial tubercle to support the TAG tower 300 on the pins 290and 390, and with the TAG tower 300 aligned on the patient's tibia 12.

Next, as shown in FIGS. 17-19, a surgeon may align the tibial slope. Thesurgeon may use an alignment method of their choice, for example, (1)use gap or “finger-breadths” at the proximal and distal ends, (2) usethe angelwing alignment member 260 to align with the distal tibia andankle joint, or (3) use the lateral rod 280 (FIG. 17) aligned to thetibial axis. In an embodiment, to begin the alignment of the tibialslope, a tibial sizing template 400 may be coupled to the distal end ofthe TAG tower 300 using a locking-cam screw. Thereafter, a first knob302 and a second knob 304 are tightened to lock the TAG tower 300 to thepins 290 and 390, and thus, to the patient's tibia 12.

Next, as shown in FIG. 18, a varus-valgus alignment may be performed.For example, the varus-valgus alignment may be performed using avarus-valgus alignment housing or double-lead screw housing 500. Thehousing 500 may include a double-lead screw 510. The double-lead screwhousing 500 allows the user to adjust varus-valgus alignment by allowingfor rotation about the screw 510. For example, the rotation is achievedby turning the knobs 512 and 514 positioned at the medial and lateralsides of the screw 510.

Optionally, as shown in FIG. 19, an internal-external rotation lockingscrew 550 may be loosened to allow for internal-external rotationadjustment of the TAG tower 300. The TAG tower 300 may include, forexample, indicators to allow the user to easily determine whether thetower 300 is internally or externally rotated or if the TAG tower 300 ispositioned at neutral.

The TAG tower 500 may also include a rack-and-pinion gear box 560. Therack- and pinion gear box 560 allows for adjustment of adistal-proximate position of a sizing template 400. Once the desireddistal-proximal position is achieved, a ball-plunger 565 and lockingscrew 567 may, for example, provide friction and lock the position ofthe rack- and pinion gear box 560.

The distal end of the TAG tower 300 may also include a second or distalvarus-valgus alignment housing or double-lead screw housing 590. Thesecond housing 590 allows for medial-lateral position adjustments. Thesecond housing 590 may include, for example, a double-lead screw 591positioned along the longitudinal axis of the second housing 590. Thesecond housing 590 may also include two knobs 592 and 594 fortranslating the coupling member 597 in the medial-lateral direction.After the desired medial-lateral alignment is achieved, a locking screwor locking cam screw 599 may be used to fix the medial-lateral positionof the attached sizing template 400. The adjustment steps may useradiographic markers on the sizing template to properly size, align andposition the instruments. Suitable alignment systems and sizingtemplates are described in international patent applicationPCT/US2019/029978, filed May 1, 2019, and entitled “Laser-Based ImplantAlignment And Resection Guide Systems And Related Methods,” the entirecontents being incorporated in herein by reference.

FIGS. 20-24 illustrate a joint-line referencing system 101, according toan embodiment of the present disclosure. For example, in someembodiments, the joint-line referencing system 101 may be operable witha fast-track alignment system 600 (FIG. 27) as described in greaterdetail below. In this illustrated embodiment, the joint-line referencingsystem 101 may be essentially the same as the joint-line referencingsystem 100 (FIGS. 1-11) having, for example, the alignment arm 200, thefirst pin tube guide member 250, the angelwing alignment member 260, thealignment foot 110 having the handle 150 and the curved shim 112 asdescribed above, but with the exception of a second pin tube guidemember 251.

FIG. 25-30 illustrate an alignment procedure, which includes ajoint-line referencing and a fast-track alignment technique for use in aTAR surgery, according to an embodiment of the present disclosure. Themethod of using the joint-line referencing system for this technique issimilar to the joint-line referencing system to TAG technique, exceptthat an additional or second 3.0 mm pin is drilled into the distal tibiaof the patient. As will be appreciated, the second pin takes the placeof the proximal pin used in the TAG technique.

As shown in FIG. 25, the surgical method includes placing the shim 112(FIG. 21) of the alignment foot 150 into the joint between the tibia 12and the talus 14 of the patient. Specifically, the shim is placedbetween the tibia plafond and the superior talar dome. The handle 150may be used, for example, to position and/or orient the alignment foot110, and thus, the coupled alignment arm 200, in the transverse plane(i.e., internal-external rotation).

Next, the angelwing alignment member 260 is inserted into the slot 232(FIG. 8) of the base portion 230 (FIG. 8) and used by a surgeon toassess the tibial slope. The joint-line referencing system may beutilized and positioned and/or orientated with respect to any axis ofthe anatomical structure of interest. After the desired orientation ofthe joint-line referencing system 101 is achieved, a first pin 290 isinserted in pin hole 256 (FIG. 20) of the first pint tube guide member250 and drilled into the tibia 12, and then a second pin 292 is insertedin a pin hole 257 (FIG. 21) of the second pin tube guide member 251 anddrilled into the tibia 12 as shown in FIG. 25. The inserted pins 290sand 292 secure the selected tibial slope and internal-externalrotation. As noted above, the irregular shaped pin tube through-holes222 (FIG. 21) in the pin tube holder 220 (FIG. 21) and the pin tubethrough-holes 216 (FIG. 21) accommodate leaving the pins 290 and 292 inthe patient's tibia upon removing the joint-line referencing system 101.

With reference to FIG. 26, the joint line referencing system 101 may beremoved, whereby the pins 290 and 292 remain inserted into the tibia 12of the patient. For example, the pin tube guide members 250 (FIG. 25)may be removed, and simultaneously the alignment arm 200 may be removedfrom the pins 290, 292 and the shim 112 (FIG. 21) removed from thejoint. These two pins are the starting point for the supporting thefast-track alignment system 600 (FIG. 27). For example, the pins 290 and292 serve as the starting point for the next portion of the surgicalprocedure, i.e., the fast-track technique.

FIG. 27 illustrates the fast-track alignment system 600 according to anembodiment of the present disclosure. In this illustrated embodiment,the fast-track alignment system 600 may include a rack-and-pinion gearbox 660, a distal varus-valgus alignment housing or double-lead screwhousing 690, and a coupling member 697. The rack-and-pinion gear box660, the distal varus-valgus alignment housing or double-lead screwhousing 690, and the coupling member 697 may be the same or essentiallythe same as the rack-and-pinion gear box, the distal varus-valgusalignment housing or double-lead screw housing, and the coupling memberas described above in connection with the TAG tower 300 (FIG. 16). Forexample, in some embodiments, this portion of the fast-track alignmentsystem may be reused from the TAG tower 300 (FIG. 16).

As shown in FIG. 28, the rack-and-pinion gear box 660 may include a pinhole 662 extending therethrough and in which the pin 292 may extend.With reference again to FIGS. 27 and 28, a distal portion 650 of thefast-track alignment system 600 may be modular and operably attachableto the distal portion the rack-and-pinion gear-box 660 using, forexample, a quarter-turn mechanism. The distal portion 650 may include acurved channel 658 (FIG. 27) in which is operably retained a slidingmember 659 (FIG. 27) having pin-holes 652 within a 3-hole pattern whichholes 652 are similarly or identically distanced a distance D from thepin-hole 662 through the rack-and-pinion gear-box 660. The pin-hole 662may be a circular or an elongated hole. The distance D may match that ofthe joint-line reference shim.

With reference to FIGS. 29 and 30, the fast-track alignment system 600is slid over the two 3.0 mm bone pins 290 and 292. The tibial slope isdefined/locked by the angle/direction of these pins. When the sizingblock 400 is attached to the fast-track reference system 600 the sizingblock is properly placed against the bone, a pin-locking knob may betightened. The varus-valgus alignment is adjusted by loosening thelocking screw 670 (FIG. 27). The pin-hole 662 in the rack-and-piniongear-box 660 aligns over the distal pin 292. This allows the user toadjust internal-external rotation by loosening an internal-externalrotation locking screw 680 (FIG. 27). The distal-proximal andmedial-lateral adjustments are made similarly to the TAG methoddescribed above.

With reference now to FIG. 31-36, therein illustrated is a joint linepointer 1000 for adjusting an alignment guide or alignment system,according to an embodiment of the present disclosure. For example, thejoint line pointer 1000 may be employed for generally setting internaland external rotation of the alignment guide such as a fast-trackalignment system 900. Additional alignment devices may include theangelwing alignment member 260, and a medial gutter tool 2000.

As shown in FIGS. 31 and 32, the fast-track alignment system 900 may bepositioned on pins 290 and 292 installed using the joint-linereferencing system 101 (FIG. 20) described above, or the joint-linereferencing system 4000 (FIG. 45) described below. The fast-trackalignment system 900 may include a first translation mechanism or mediallateral adjustment member, a second translation mechanism or distalproximal adjustment member, and third translation mechanism orvarus-valgus adjustment member, similar to the adjustment member andsystems described above with the fast-track alignment system 600 (FIG.27).

As shown in FIGS. 37-40, the joint line pointer 1000 may generallyinclude a body 1100 and a handle 1200 having one end 1202 attached tobody 1100. With reference to FIG. 37, body 1000 may include an upperportion 1002 and lower portion 1004. The upper portion 1002 may includea coupling member 1110 that is receivable in the coupling member 910(FIG. 32) of the fast-track alignment system 900 (FIG. 32). The lowerportion 1004 includes a slot 1032 for receiving a tab 274 (FIG. 35) ofthe angelwing alignment member 260 (FIG. 35) and laterally-extendingportions 1112 for assessing the joint line.

FIGS. 41-44 illustrates another joint line pointer 3000, according to anembodiment of the present disclosure. In this illustrated embodiment,the joint line pointer 3000 may generally include a body 3100 and ahandle 3200 having one end 3202 attached to body 3100. As shown in FIG.41, the body 3000 may include an upper portion 3002 and lower portion3004. The upper portion 3002 may include a coupling member 3110 that isreceivable in the coupling member 910 (FIG. 32) of the fast-trackalignment system 900 (FIG. 32). The lower portion 3004 includes athrough opening 3300 and laterally-extending feet 3115. The feetextended medially and laterally to indicate the joint line.

With reference again to FIG. 35, the medial gutter tool 2000 may havingan elongated body 2010 having a first portion 2002 and a second portion2004. The first portion 2002 may be Y-shaped, and the second portion2004 may be a reduced or tapered distal end.

With reference again to FIG. 31, once the fast-track alignment system900 is positioned on the pins 290 and 292, the joint line pointer suchas the joint line pointer 1000 (or the joint line pointer 3000 (FIG.41)), and the medial gutter tool 2000 may be operably employed by asurgeon to move and align the fast-track alignment system 900 in properorientation relative to the lower extremity of the patient. The medialgutter tool 2000 may be used along the medial gutter plane or to adetermined gutter bisection. Once in proper alignment, position, andorientation, the fast-track alignment system may be operably lockablysecured in place on the pins attached to the lower extremity of thepatient's tibia. The joint line pointer and gutter tool may be used withthe any of the above TAR and fast-track alignment systems.

The above alignment systems, e.g., TAG and fast-track alignment systems,joint line pointers, and gutter tools may be operably usable withsuitable resection guides and other tools for performing total anklereplacement. For example, the above alignment systems may be operablewith the resection guides described in U.S. provisional patentapplication No. 62/898,615, filed Sep. 11, 2019, and entitled “ResectionGuides, Sweeping Reamers, And Methods For Use In Total AnkleReplacement” (Attorney Docket No. 3645.158P1), the entire contents beingincorporated in herein by reference. Other suitable fast-track alignmentsystem may be used with the joint-line reference systems of the presentdisclosure. For example, suitable fast-track alignment systems aredescribed in U.S. Provisional Application No. 62/899,703 filed Sep. 11,2019, entitled “Joint Replacement Alignment Guides, Systems And MethodsOf Use And Assembly” (Attorney Docket No. 3645.155P1), which is herebyincorporated by reference in its entirety. Other suitable tibialalignment guide system may be used with the joint-line reference systemsof the present disclosure. For example, suitable tibial alignment guidesystems are described in U.S. Provisional Application No. 62/899,740,filed Sep. 12, 2019, entitled “Joint Replacement Alignment Guides,Systems And Methods Of Use And Assembly” (Attorney Docket No.3645.157P1), which is hereby incorporated by reference in its entirety.

FIG. 45 illustrates a joint-line referencing system 4000, according toan embodiment of the present disclosure. For example, in someembodiments, the joint-line referencing system 4000 is operable with theTAG tower 300 (FIG. 16), the fast-track alignment system 600 (FIG. 27),and/or with a laser alignment system 5000 (FIG. 62). In this illustratedembodiment, the joint-line referencing system 4000 may include, forexample, an alignment foot 4100 having a handle 4150 and a flat shim4170, an alignment arm 4200, a first pin tube guide member 4250, asecond pin tube guide member 4251, an angelwing alignment member 4300,and an alignment rod 4400.

With reference to FIGS. 46-55, the alignment arm 4200 may include a body4210 having a first portion 4212, a second portion 4214, a first side4213, and a second side 4215. The first portion 4212 of the alignmentarm 4200 may include a pin tube holder 4220 defining at least one pintube through-hole 4222 extending from the first side 4213 to the secondside 4215 for receiving the pin tube guide member 4250 (FIG. 45). A pintube through-hole 4216 extends from the first side 4213 to the secondside 4215 and is operable for receiving the second pin tube guide member4250 (FIG. 45) for use with, for example, the fast-track alignmentsystem 600 (FIG. 27) and/or the laser alignment system 5000 (FIG. 62).The at least one pin tube through-holes 4222 may be separate individualside-by-side openings or a plurality of overlapping pin tube openingsthat allow for anatomic variations. The at least one pin tubethrough-hole 4222 may be, for example, three holes as shown in thedepicted embodiment to allow for anatomic variations. The pin tubethrough-holes 4222 and the pin tube through-hole 4216 may be circularfor receiving the cylindrical pin tube 4250 (FIG. 45). As shown in FIG.54, for example, the alignment arm may define a longitudinal axis Z, pintube through-hole 4216 may define an axis X1. Each of the pin tubethrough-holes 4222 may define axes X2, X3, and X4.

With reference to FIGS. 54 and 55, the second portion 4214 of thealignment arm 4200 may include a first base portion 4230 having anopening such as a slot 4232 opening onto the first side 4213 forreceiving an auxiliary alignment instrument such as a tab 4370 (FIG. 52)of the angelwing alignment member 4300 (FIG. 52), or a laser alignmentdevice (not shown), or other suitable alignment device. The secondportion 4214 of the alignment arm 4200 may include a spaced apart secondbase portion 4240 having an opening such as a slot 4242 on the firstside 4213 for receiving an auxiliary alignment instrument such as thelaser alignment device 5000 (FIG. 62) as described below. Slots 4232 and4242 may extend through body 4210 of alignment arm 4200 and beconfigured to open onto the first side 4213 and second side 4215. Theopenings 4232 and 4242 may be configured to allow for orienting thealignment angelwing member and/or the laser. As shown in FIG. 54, forexample, each of the slots 4232 and 4242 may define axes X5 and X6,respectively. Pin tube through-hole axis X1-X4 and slot axis X5 and X6may be parallel to each other, and disposed at 90 degrees from axis Z ofthe alignment arm.

A distal end of the first base portion 4230 may further include anoutwardly-extending tab 4260 having a through-hole 4266 extendingtherethrough. A pair of pin holes 4261 and 4263 may extend through theoutwardly extending tab 4260 for use with pins 4265 (FIG. 52) to attachthe alignment foot 4100 (FIG. 45) to alignment arm 4200 as describedbelow.

With reference again to FIG. 45, the pin tube guide members 4250 and4251 may be essentially the same as pin tube guide members 250 (FIG. 1)described above. The angelwing alignment member 4300 may essentially thesame as the angelwing alignment member 260 (FIG. 1) described above.

The angelwing alignment member 4300 allows a surgeon to assess thetibial slope. For example, the alignment rod 4400 may be movably coupledto the wing member 4300, such as within an elongated opening 4364 of theangelwing alignment member 4300, which elongated opening may extendanteriorly-posteriorly. The rod 4400 may be oriented perpendicularly (inat least one direction) or normal to the angelwing alignment member4300, and thereby perpendicular (in at least one direction) or normal tothe joint line referenced by the slot 4232 (FIG. 54) in the first baseportion 4230 (FIG. 54), the slot 4242 (FIG. 54) in the second baseportion 4240 (FIG. 54), and the angelwing alignment wing member 4300.The rod 4400 may thereby allow a surgeon to determine/evaluate thealignment (e.g., sagittal alignment) and/or orientation (e.g., sagittalslope and/or coronal slope) of the joint line of the anatomicalconfiguration/structures of the patient (e.g., an ankle joint) and/or ofa particular implant replacing such configuration/structures (e.g., atotal ankle replacement implant) implanted on/in a resected bone that isresected (at least partially).

With reference again to FIGS. 52 and 53, the alignment foot 4100 mayinclude the handle 4150 and the flat shim 4170 operably attachable tothe alignment arm 4200. For example, the handle 4150 may be fixedlyattachable to the alignment arm 4200 with a connector portion 4151 ofthe handle 4150 receivable in the through-hole 4266 (best shown in FIG.54) via a fastener pin 4152 (FIG. 53), or screw, or other suitablefastening member. The shim 4170 is fixedly attachable to the alignmentarm 4200 with a connector portion 4171 of the shim 4170 receivable inthe through-hole 4266 (best shown in FIG. 55) via a fastener pin 4172(FIG. 53), or screw, or other suitable fastening member. The fixedconnection of the handle 4150, the shim 4170, and the alignment arm 4200allows a surgeon using the handle 4150 to adjust the position andorientation of the joint-line referencing system 4100 (FIG. 45) relativeto, for example, a joint between adjacent bones. The handle 4150 may beplanar to easily allow a surgeon to grasp and reposition the handle, andthus position and orient the joint-line referencing system 4100 (FIG.45).

With reference to FIGS. 56-59, the shim 4170 may include the connector4171 and a generally planar portion 4174 having a first flat surface4175 and a second flat surface 4176. In some embodiments, the shim 4170may be a generally square planar member with rounded corners and withthe first flat surface 4175 and the second flat surface 4176 taperingtowards a distal end of the shim. For example, as shown in FIG. 59, thefirst flat surface 4175 and the second flat surface may be disposed atan angle S of about 0 degrees to about 10 degrees, about 2 degrees toabout 8 degrees, about 4 degrees to about 6 degrees, about 0 degrees, 2degrees, about 4 degrees, about 5 degrees, about 6 degrees, about 7degrees, about 8 degrees, or disposed at any suitable angle. The shim4170 is designed to fit in the joint between adjacent bones such asbetween the talus and tibia of an ankle joint in anterior-posterior andmedial-lateral directions. The generally planar portion 4174 of the shim4170 may define a longitudinal axis X7 parallel with the axes of the pinthough-holes and slots in the alignment arm 4200 (FIG. 54.).

With reference again to FIGS. 56-59, the connector 4171 of the shim 4170is offset relative to the generally planar portion 4174. This allows, asshown in FIG. 49, for the generally planar portion 4174 of the shim 4170to be disposed parallel and in line with angelwing alignment member 4300in the assembled joint line referencing system 4000 (FIG. 45).

FIGS. 60 and 61 illustrate the initial steps of an alignment procedure,which may subsequently include the joint-line referencing system 4000for use in the TAG technique in a TAR surgery, according to anembodiment of the present disclosure.

For example, for use in the TAG technique in a TAR surgery, the initialsteps of an alignment procedure may include placing the shim 4170 (FIG.61) of the alignment foot 4100 (FIG. 61) into the joint 10 between,e.g., the tibia 12 and the talus 14 of the patient. Specifically, theshim 4170 (FIG. 61) is placed between the tibia plafond and the superiortalar dome. The handle 4150 (FIG. 61) may be used, for example, toposition and/or orient the alignment foot 4100, and thus, the coupledalignment arm 4200, in the transverse plane (i.e., internal-externalrotation).

Next, the angelwing alignment member 4300 inserted into the slot 4232(FIG. 54) of the base portion 4230 (FIG. 54) may be used by a surgeon toassess the tibial slope. The rod 4400 may be used to determine/evaluatethe alignment (e.g., sagittal alignment) and/or orientation (e.g.,sagittal slope and/or coronal slope) of the joint line of the anatomicalconfiguration/structures of the patient (e.g., an ankle joint). As shownin FIG. 60, the joint-line referencing system 4000 may be utilized andpositioned and/or orientated with respect to any axis X-X of theanatomical structure of interest. With reference again to FIG. 61, afterthe desired position and/or orientation of the joint-line referencingsystem 4000 is achieved, a first pin 4290 is inserted in pin hole 4256(FIG. 45) of first guide member 4250 and drilled into the tibia 12. Theinserted pin 4290 secures the selected tibial slope andinternal-external rotation.

In some embodiments, the joint line referencing system 4000 may beremoved, whereby the first pin 4290 remains inserted into the tibia 12.For example, the pin tube guide member 4250 may be removed, andsimultaneously the alignment arm 4200 may be removed from the pin 4290and the shim 4170 removed from the joint. The first pin 4290 serves asthe starting point for the next portion of the surgical procedure, i.e.,the TAG technique. The inserted pin 4290 may be employed with a tibiaalignment guide (TAG) technique for use in a TAR surgery, for example,as illustrated in FIGS. 16-19 and described above.

In other embodiments and with reference again to FIGS. 60 and 61, theinitial steps of an alignment procedure may subsequently include thejoint-line referencing system 4000 for use in the fast-track alignmenttechnique in a TAR surgery.

For example, for use in the fast-track alignment technique in a TARsurgery, the initial steps of an alignment procedure may include placingthe shim 4170 (FIG. 61) of the alignment foot 4100 (FIG. 61) into thejoint 10 between, e.g., the tibia 12 and the talus 14 of the patient.Specifically, the shim 4170 (FIG. 61) is placed between the tibiaplafond and the superior talar dome. The handle 4150 (FIG. 61) may beused, for example, to position and/or orient the alignment foot 4100,and thus, the coupled alignment arm 4200, in the transverse plane (i.e.,internal-external rotation).

Next, the angelwing alignment member 4300 is inserted into the slot 4232(FIG. 54) of the base portion 4230 (FIG. 54) may be used by a surgeon toassess the tibial slope. The rod 4400 may be used to determine/evaluatethe alignment (e.g., sagittal alignment) and/or orientation (e.g.,sagittal slope and/or coronal slope) of the joint line of the anatomicalconfiguration/structures of the patient (e.g., an ankle joint). As shownin FIG. 60, the joint-line referencing system 4000 may be utilized andpositioned and/or orientated with respect to any axis X-X of theanatomical structure of interest. After the desired position and/ororientation of the joint-line referencing system 4000 is achieved, afirst pin 4290 is inserted in pin hole 4256 (FIG. 45) of first guidemember 4250 (FIG. 61) and drilled into the tibia 12, and then a secondpin 4292 (FIG. 61) is inserted in the pin hole of the second pin tubeguide member 4251 (FIG. 61) and drilled into the tibia 12. The insertedpins 4290 (FIG. 61) and 4292 (FIG. 61) secure the selected tibial slopeand internal-external rotation. The method of using the joint-linereferencing system for this technique is similar to the joint-linereferencing system to the TAG technique, except that the additionalsecond pin 4292 is drilled into the distal tibia of the patient. As willbe appreciated, the second pin 4292 takes the place of the proximal pinused in the TAG technique.

The joint line referencing system 4000 may be removed, whereby the firstpin 4290 and the second pin 4292 remain inserted into the tibia 12. Forexample, the pin tube guide members 4250 (FIG. 61) and 4251 (FIG. 61)may be removed, and simultaneously the alignment arm 4200 may be removedfrom the pins 4290, 4292 and the shim 4170 (FIG. 61) removed from thejoint. These two pins are the starting point for the supporting, forexample, the fast-track alignment system 600 (FIG. 27). For example, thepins 4290 and 4292 serve as the starting point for the next portion ofthe surgical procedure, i.e., the fast-track technique. The insertedpins 4290 and 4292 may be employed with the fast-track alignment system600 (FIG. 27) for use in a TAR surgery, for example, as illustrated inFIGS. 27-30 and described above.

With reference to FIG. 62, therein illustrated is the joint-linereferencing system 4000 with a laser alignment system 5000, according toan embodiment of the present disclosure. For example, in someembodiments, the joint-line referencing system 4000 with the laseralignment system 5000 may be operable with the TAG tower 300 (FIG. 16)or with the fast-track alignment system 600 (FIG. 27) for use in a TARsurgery. As described in greater detail below, the laser alignmentsystem 5000 may be operably connected to the joint-line referencingsystem 4000 via the slot 4242 (FIG. 54) of base member 4240 (FIG. 54) ofalignment arm 4200.

As shown in FIGS. 63-65, the laser alignment system 5000 may generallyinclude a housing 5100, a laser device 5200, an insert shim 5300, apower source holder or battery holder 5400 (FIG. 64), and one or morepower sources such as a plurality of batteries 5600 (FIG. 64). A distalend of the insert shim 5300 extends from the housing 5100. The distalend of the insert shim 5300 is receivable in the slot 4242 (FIG. 54) ofbase member 4240 (FIG. 62) of the alignment arm 4200 (FIG. 63). Thehousing 5100 may include a first half 5110 and a second half 5120. Thelaser device 5200 may be disposed at an angle relative to the insertshim 5300.

With reference to FIG. 65, the insert shim 5300 may include a firstportion 5310 and a second portion 5350. The first portion 5310 of theinsert shim 5300 may have a distal end 5311 and a proximal end 5312having a cutout 5314 configured and angled for receiving and positioningthe laser device 5200. The second portion 5350 of the insert shim 5300may have a distal end 5351 and a proximal end 5352. The distal end 5351may act as an electrical switch for turning on the laser device 5200when the distal end of the insert shim is inserted in slot 4242 (FIG.54) of alignment arm 42 (FIG. 54).

FIGS. 66 and 67 illustrate the joint-line referencing system 4000 withthe laser alignment system 5000 aligned relative to a patient's lowerextremity, according to an embodiment of the present disclosure. Thecombination of the alignment foot 4100 (FIG. 66), alignment arm 4200,the angelwing alignment member 4300, the alignment rod 4400, and thelaser alignment system 5000 may be used by a surgeon to orient andposition joint-line referencing system 4000 relative to a patient'slower extremity. In this illustrated embodiment, the laser alignmentsystem 5000 may emit laser light therefrom orientated at a fixed anglerelative to alignment arm 4200. The emitted and projected laser lightmay be in a plane over an angle W resulting in an illuminated laser line5500 (illustrated in dashed lines in FIG. 67) on the patient's lowerextremity (e.g., on the outer skin surface of the patent's lowerextremity) when the distal end 5351 (FIG. 65) acting as a switchactivates the laser device 5000 (FIG. 66). As shown in FIG. 67, thelaser light line 5500 can be aligned to the alignment axis (e.g., ananatomical or mechanical axis) of the anatomicalconfiguration/structures of the patient via the surgeon positioning andorientating the joint-line referencing system 4000.

In some embodiments, the laser device 5200 may be configured to emit afan shaped laser light plane with a fan angle within the range of about1 degree to about 75 degrees (e.g., 1, 5, 10, 20, 30, 45, 60, or 75degrees). In some embodiments, the laser device 5200 may be configuredto emit a fan shaped laser light plane with a fan angle of about 60degrees. In some embodiments, the laser device 5200 may be configured toemit a laser light plane with a beam angle of less than 3 rad. Inalternative embodiments, the laser light may emanate in configurationsother than a laser line (i.e., the incident light may form a point ordot).

In some embodiments, in addition to emitting a linear laser line 5500(via a fan shaped laser light plane), the laser device 5200 may beconfigured to emit at least one secondary linear laser line (not shown)(e.g., via a fan shaped laser light plane), which may be orientatedperpendicular to the linear laser line 5500. The secondary linear laserline may further assist the surgeon in properly positioning andorienting the joint-line referencing system 4000 with respect to theanatomical configuration/structures of the patient (e.g., to thealignment axis (e.g., an anatomical or mechanical axis) of theanatomical configuration/structures of interest).

FIG. 68 illustrates a surgical method 6000, according to an embodimentof the present disclosure. For example, the method 6000 may include at6100 placing a shim into a joint between a first bone and a second boneof a patient, at 6200 moving a handle operably attached to the shim toposition and/or orient an alignment arm relative to the first bone, at6300 inserting a first pin through a hole of the alignment arm and intothe first bone, at 6400 removing the shim from the joint and thealignment arm from the first pin, at 6500 installing an alignment guideon the installed first pin, and at 6600 using a cutting guide operablyattached to the alignment guide to resect a portion of the first boneand/or the second bone.

FIG. 69 illustrates a surgical method 7000, according to an embodimentof the present disclosure. For example, the method 7000 may include at7100, placing a shim into a joint between a first bone and a second boneof a patient, at 7200 moving a handle operably attached to the shim toposition and/or orient an alignment arm relative to the first bone, at7300 inserting a first pin through a first hole of the alignment arm andinto the first bone, at 7400 inserting a second pin through a secondhole of the alignment arm and into the first bone, at 7500 removing theshim from the joint and the alignment arm from the first and the secondpins, at 7600 installing an alignment guide on the installed pins, at7700 using a cutting guide operably attached to the alignment guide toresect a portion of the first bone and/or the second bone.

In the various embodiments of the joint line systems and methods of thepresent disclosure may be configured to provide alignment (e.g.,manipulation to achieve alignment) in three planes (e.g., along or inthe sagittal, coronal and transverse planes), covering six degrees offreedom.

The above disclosure describes a portion of a total ankle replacement(TAR) procedure and the devices used in that procedure. Additionalunderstanding of the TAR procedure may be found in U.S. ProvisionalApplication No. 62/779,436 filed Dec. 13, 2018, and entitled JointReplacement Systems and Methods of Use and Assembly (Attorney Docket No.3645.138P1), International Application No. PCT/US2019/029009 filed Apr.24, 2019, and entitled Implants and Methods of Use and Assembly(Attorney Docket No. 3645.139AWO), U.S. Provisional Application No.62/779,092 filed Dec. 13, 2018, and entitled Instruments, Guides andRelated Methods for Total Ankle Replacement (Attorney Docket No.3645.144P), International Application No. PCT/US2019/066404 filed Dec.13, 2019, and entitled Instruments, Guides and Related Methods for TotalAnkle Replacement (Attorney Docket No. 3645.144AWO), U.S. ProvisionalApplication No. 62/890,611 filed Aug. 22, 2019, and entitled PatientSpecific Instruments and Methods of Use (Attorney Docket No. 3645.152P),International Application No. PCT/US2019/066336 filed Dec. 13, 2019, andentitled Patient Specific Instruments and Methods of Use (AttorneyDocket No. 3645.152AWO), U.S. Provisional Application No. 62/899,703filed Sep. 12, 2019, and entitled Joint Replacement Alignment Guides,Systems and Methods of Use and Assembly (Attorney Docket No.3645.155P1), International Application No. PCT/US2019/066408 filed Dec.13, 2019, and entitled Joint Replacement Alignment Guides, Systems andMethods of Use and Assembly (Attorney Docket No. 3645.155AWO), U.S.Provisional Patent Application No. 62/899,655, filed Sep. 12, 2019, andentitled Alignment Instruments And Methods For Use In Total AnkleReplacement (Attorney Docket No. 3645.156P1), International ApplicationNo. PCT/US2019/066149, filed on Dec. 13, 2019, and entitled AlignmentInstruments And Methods For Use In Total Ankle Replacement (AttorneyDocket No. 3645.156AWO), U.S. Provisional Application No. 62/899,740filed Sep. 12, 2019, and entitled Joint Replacement Alignment Guides,Systems and Methods of Use and Assembly (Attorney Docket No.3645.157P1), International Application No. PCT/US2019/066393 filed Dec.13, 2019, and entitled Joint Replacement Alignment Guides, Systems andMethods of Use and Assembly (Attorney Docket No. 3645.157AWO), U.S.Provisional Application No. 62/898,615 filed Sep. 11, 2019, and entitledResection Guides, Sweeping Reamers, and Methods for Use in Total AnkleReplacement (Attorney Docket No. 3645.158P1), International ApplicationNo. PCT/US2019/064948 filed Dec. 6, 2019, and entitled Resection Guides,Sweeping Reamers, and Methods for Use in Total Ankle Replacement(Attorney Docket No. 3645.158AWO), U.S. Provisional Application No.62/898,854 filed Sep. 11, 2019, and entitled Distractors HavingAttachable Paddles, Impaction Devices, and Methods for Use in TotalAnkle Replacement (Attorney Docket No. 3645.159P1), InternationalApplication No. PCT/US2019/066398 filed Dec. 13, 2019, and entitledDistractors Having Attachable Paddles, Impaction Devices, and Methodsfor Use in Total Ankle Replacement (Attorney Docket No. 3645.159AWO),U.S. Provisional Application No. 62/899,646 filed Sep. 12, 2019, andentitled Trial Insert Assembly (Attorney Docket No. 3645.160P1),International Application No. PCT/US2019/065025 filed Dec. 6, 2019, andentitled Trial Insert Assembly (Attorney Docket No. 3645.160AWO), U.S.Provisional Application No. 62/899,460 filed Sep. 12, 2019, and entitledTotal Ankle Replacement Surgical Method (Attorney Docket No.3645.161P1), International Application No. PCT/US2019/066409 filed Dec.13, 2019, and entitled Total Ankle Replacement Surgical Method (AttorneyDocket No. 3645.161AWO), which are each hereby incorporated herein intheir entireties.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the presentdisclosure. As used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”), “contain” (and any form contain, such as “contains” and“containing”), and any other grammatical variant thereof, are open-endedlinking verbs. As a result, a method or article that “comprises”, “has”,“includes” or “contains” one or more steps or elements possesses thoseone or more steps or elements, but is not limited to possessing onlythose one or more steps or elements. Likewise, a step of a method or anelement of an article that “comprises”, “has”, “includes” or “contains”one or more features possesses those one or more features, but is notlimited to possessing only those one or more features. Any examples ofparameters are not exclusive of other parameters of the disclosedembodiments.

As used herein, the terms “comprising,” “has,” “including,”“containing,” and other grammatical variants thereof encompass the terms“consisting of” and “consisting essentially of.” The phrase “consistingessentially of” or grammatical variants thereof when used herein are tobe taken as specifying the stated features, integers, steps orcomponents but do not preclude the addition of one or more additionalfeatures, integers, steps, components or groups thereof but only if theadditional features, integers, steps, components or groups thereof donot materially alter the basic and novel characteristics of the claimedcompositions or methods.

All publications cited in this specification are herein incorporated byreference as if each individual publication were specifically andindividually indicated to be incorporated by reference herein as thoughfully set forth.

Where one or more ranges are referred to throughout this specification,each range is intended to be a shorthand format for presentinginformation, where the range is understood to encompass each discretepoint within the range as if the same were fully set forth herein.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Numerous changes and modificationsmay be made herein by one of ordinary skill in the art without departingfrom the general spirit and scope of the disclosure as defined by thefollowing claims and the equivalents thereof. For example, theabove-described embodiments (and/or aspects thereof) may be used incombination with each other. In addition, many modifications may be madeto adapt a particular situation or material to the teachings of thevarious embodiments without departing from their scope. While thedimensions and types of materials described herein are intended todefine the parameters of the various embodiments, they are by no meanslimiting and are merely exemplary. Many other embodiments will beapparent to those of skill in the art upon reviewing the abovedescription. The scope of the various embodiments should, therefore, bedetermined with reference to the appended claims, along with the fullscope of equivalents to which such claims are entitled.

In the appended claims, the terms “including” and “in which” are used asthe plain-English equivalents of the respective terms “comprising” and“wherein.” Moreover, in the following claims, the terms “first,”“second,” and “third,” etc. are used merely as labels, and are notintended to impose numerical requirements on their objects. Also, theterm “operably connected” is used herein to refer to both connectionsresulting from separate, distinct components being directly orindirectly coupled and components being integrally formed (i.e.,monolithic). Further, the limitations of the following claims are notwritten in means-plus-function format and are not intended to beinterpreted based on 35 U.S.C. § 112, sixth paragraph, unless and untilsuch claim limitations expressly use the phrase “means for” followed bya statement of function void of further structure.

It is to be understood that not necessarily all such objects oradvantages described above may be achieved in accordance with anyparticular embodiment. Thus, for example, those skilled in the art willrecognize that the systems and techniques described herein may beembodied or carried out in a manner that achieves or optimizes oneadvantage or group of advantages as taught herein without necessarilyachieving other objects or advantages as may be taught or suggestedherein.

While the disclosure has been described in detail in connection withonly a limited number of embodiments, it should be readily understoodthat the invention is not limited to such disclosed embodiments. Rather,the invention can be modified to incorporate any number of variations,alterations, substitutions or equivalent arrangements not heretoforedescribed, but which are commensurate with the spirit and scope of theinvention. Additionally, while various embodiments of the invention havebeen described, it is to be understood that aspects of the disclosuremay include only some of the described embodiments.

Components, aspects, features, configurations, arrangements, uses andthe like described, illustrated or otherwise disclosed herein withrespect to any particular embodiment may be similarly applied to anyother embodiment disclosed herein. Accordingly, the inventions are notto be seen as limited by the foregoing description, but is only limitedby the scope of the appended claims.

This written description uses examples to disclose the inventions,including the best mode, and also to enable any person skilled in theart to practice the inventions, including making and using any devicesor systems and performing any incorporated methods. The patentable scopeof the inventions are defined by the claims, and may include otherexamples that occur to those skilled in the art. Such other examples areintended to be within the scope of the claims if they have structuralelements that do not differ from the literal language of the claims, orif they include equivalent structural elements with insubstantialdifferences from the literal language of the claims.

What is claimed is:
 1. A joint-line referencing system comprising: analignment arm comprising a body having a first portion and a secondportion, said first portion and said second portions defining a firstside and a second side, said first portion having at least one first pintube through-hole extending from said first side to said second side,the second portion having a first opening on said first side; a firstpin tube guide member receivable in said at least one first pin tubethrough-hole, said first pin tube guide member having a passagewaytherethrough; an angelwing alignment member having a portion receivablein said at least one first opening of said alignment arm; an alignmentfoot secured to said second portion, said alignment foot having a handleextending away from said first side and a shim extending away from saidsecond side; and wherein said shim is positionable in a joint between afirst bone and a second bone, said alignment arm is alignable relativeto a first bone, and said pin tube guide is operable for securing a pininto the first bone.
 2. The joint-line referencing system of claim 1,wherein said alignment arm comprises a second pin tube-hole disposedbetween said at least one first pin tube through-hole and said firstopening, and further comprising a second pin tube guide memberreceivable in said second pin tube through-hole, said second pin tubeguide member having a passageway therethrough.
 3. The joint-linereferencing system of claim 1, wherein said shim comprises a first flatsurface and a second flat surface.
 4. The joint-line referencing systemof claim 3, wherein said first flat surface of said shim is angledrelative to said second flat surface.
 5. The joint-line referencingsystem of claim 1, wherein said shim comprises a longitudinal axisdisposed parallel to an axis of said at least one first pin tubethrough-hole.
 6. The joint-line referencing system of claim 1, whereinsaid shim is disposed in alignment with said first opening so that saidshim is disposed in alignment with said angelwing alignment member. 7.The joint-line referencing system of claim 1, wherein said shimcomprises a connector offset from said first surface and said secondsurface, and said connector is connectable to said second portion ofsaid body of said alignment arm spaced from said first opening.
 8. Thejoint-line referencing system of claim 7, wherein said handle isconnectable to said second portion of said body of said alignment armspaced from said first opening, and said handle is aligned with saidconnector of said shim.
 9. The joint-line referencing system of claim 1,wherein said shim and said handle of said alignment foot are fixedlyconnected to said second portion of said alignment arm.
 10. Thejoint-line referencing system of claim 1, wherein said portion of saidangelwing alignment member comprises a tab, and said first opening ofsaid alignment arm comprises a slot for receiving said tab of saidangelwing alignment member.
 11. The joint-line referencing system ofclaim 1, wherein said second portion comprises a second opening on saidfirst side for receiving a second alignment device, said second openingdisposed between said first opening and said at least one first pin tubethrough-hole.
 12. The joint-line referencing system of claim 11, furthercomprising said second alignment device comprising a laser alignmentsystem.
 13. The joint-line referencing system of claim 12, wherein saidlaser alignment system is operable to project a laser line alignablewith the first bone.
 14. The joint-line referencing system of claim 11,wherein said first opening comprises a first slot, and said secondopening comprises a second slot parallel to said first slot.
 15. Thejoint-line referencing system of claim 1, wherein said shim comprise acurved shim.
 16. The joint-line referencing system of claim 15, whereinsaid alignment foot is pivotably attachable to said second portion ofsaid alignment arm.
 17. The joint-line referencing system of any ofclaim 1, wherein said at least one first pin tube through-hole comprisesseparate individual side-by-side openings or a plurality of overlappingpin tube openings.
 18. The joint-line referencing system of claim 17,wherein said pin tube holes are oblong or elongated.
 19. The joint-linereferencing system of claim 1, wherein said angelwing alignment membercomprises a planar L-shaped angelwing alignment member.
 20. Thejoint-line referencing system of claim 1, wherein a first leg of saidL-shaped angelwing alignment member comprises a tab receivable in saidfirst opening, and a second leg of said L-shaped angelwing alignmentmember comprises an elongated opening, and further comprising analignment rod extendable through said elongated opening and attachableto said angelwing alignment member.
 21. The joint-line referencingsystem of claim 1, wherein said first portion of said alignment arm isangled relative to said second portion of said alignment arm.